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Pharma Manufacturing | Pharmaceutical Manufacturing | FiercePharmaManufacturing | fiercepharmamanufacturing.com Reviews

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Find the latest pharmaceutical manufacturing news on automation & control, supply chains, GMP, anticounterfeiting, and other pharma manufacturing news.

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Validation and Quality Blogging Insights. Qualification/validation and quality related topics for the pharmaceutical and biopharmaceutical industries. The Responsibilities and Failures of the Quality Unit. September 2, 2012. English: US Government instruction manual on Quality Systems; free content. http:/ www.fda.gov/CbER/gdlns/qualsystem1.gif. The responsibilities of the Quality Control Unit are specified in 21 CFR 211.22. [Ref. # 3]. Specifically, the QCU shall have:. Responsibilities and procedures a...

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To Clean Or Not To Clean—An Audit Case of Misinterpreting the Good Manufacturing Practices | Validation & Quality Blogging Insights

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Validation and Quality Blogging Insights. Qualification/validation and quality related topics for the pharmaceutical and biopharmaceutical industries. To Clean Or Not To Clean An Audit Case of Misinterpreting the Good Manufacturing Practices. August 11, 2012. Is the auditee’s response deemed acceptable? Should the auditor close out this observation? Minimum CGMP Regulatory Requirements. Assessment of Audit Response. The auditee failed to maintain cleaning records for the washing area of the laboratory so...

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Canadian GMP Regulations Applicable to Procedures | Validation & Quality Blogging Insights

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Validation and Quality Blogging Insights. Qualification/validation and quality related topics for the pharmaceutical and biopharmaceutical industries. Canadian GMP Regulations Applicable to Procedures. June 18, 2012. A key element for Good Manufacturing Practices. GMPs) is approved procedures. May be used to supplement product-specific master and batch production documents”. Following SOPs ensures that drugs are consistently produced and controlled in such a way to meet the quality standards ap...The Can...

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